Anti-aging Efficacy of Food Supplement and Cosmetic Routine

Not Applicable

Active, not recruiting

• Conditions: Aging; Wrinkle

• Registration Number: NCT06932770
• Lead Sponsor: Amazentis SA

Brief Summary

The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-17
• Study Start: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Written Informed Consent to participate in the study
• Willingness to actively participate in the study and to come to the scheduled visits
• Female
• From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
• Healthy skin in the test areas
• Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)

For biopsy subpanel:

• Vaccination of tetanus within the last 10 years

Exclusion Criteria

• Female subjects: Pregnancy or lactation
• Drug addicts, alcoholics
• AIDS, HIV-positive or infectious hepatitis
• Conditions which exclude a participation or might influence the test reaction/evaluation
• Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
• Active skin disease at the test area
• Documented allergies to face/eye care products and food supplements or their ingredients
• Intake of dietary supplements within the last 3 months before the start of the study
• Diabetes mellitus
• Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
• One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
• Epilepsy
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
• Regular use of tanning beds
• Any topical medication at the test area within the last 3 days prior to the start of the study
• Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
• Therapy with antibiotics within the last 2 weeks prior to the start of the study
• Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
• Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study
• Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study

For biopsy subpanel:

• Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
• History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
• Known intolerance to local anaesthetics
• Known Sensitivity to any dressing systems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-wrinkle efficacy	12 weeks	Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).

Secondary Outcome Measures

Name	Time	Method
Skin barrier function	12 weeks	Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter \[g/(m²h)\]) after 6 and 12 weeks
Skin hydration	12 weeks	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 6 and 12 weeks
Skin firmness	12 weeks	Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer \[mm\]) after 6 and 12 weeks
Skin elasticity	12 weeks	Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 6 and 12 weeks
Wrinkles and fine lines	12 weeks	Change from baseline for wrinkles and fine lines (assessed on VISIA-CR Image analysis) after 6 and 12 weeks
Skin aging hallmarks	12 weeks	Change from baseline in skin hallmarks of aging (assessed on 3mm punch skin biopsies) after 12 weeks in a subpanel of participants
Product traits	12 weeks	Subjective evaluation of product traits assessed via questionnaire after 6 and 12 weeks.; Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick: * 2 = Fully disagree; * 1 = Rather disagree; 1. = Rather agree; 2. = Fully agree

Trial Locations

Locations (1)

SGS proderm GmbH; 🇩🇪 Schenefeld, Hamburg, Germany